2024 Drug Safety Communications
2024 Drug Safety Communications
Ongoing | Non-malignant Hematological, Neurological, and Other Disorder Indications Accelerated Approvals
Drug and Biologic Accelerated Approvals Based on a Surrogate Endpoint
Competitive Generic Therapy Approvals
Explore the FDA’s Competitive Generic Therapy Approvals page, offering insights into the program designed to encourage generic drug competition. Access…
Anti‐Doping Testing at FIFA World Cup 2022
The FIFA 2022 World Cup was fully accomplished by the Anti-Doping Lab Qatar. The article describes the doping analysis work,…
Drugs@FDA Data Files
Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)
Zenzi Pharmaceutical Industries Pvt. Ltd. – 701130 – 02/13/2025
Refusal to Provide Access to and Copying of Records
About BeSafeRx
“FDA’s BeSafeRx: Your Source for Online Pharmacy Information” is a national campaign to educate consumers and health care professionals about…
Tyche Industries Ltd – 693081 – 02/06/2025
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
AmWiner & Raphe Holdings, LLC dba rapheGenerics Corp – 698782 – 01/29/2025
CGMP/Finished Pharmaceuticals/Adulterated
NDA and BLA Calendar Year Approvals
NDA and BLA Calendar Year Approvals